Doruksistem AS
DORUKSISTEM Engineering Technology and Consultancy Co. Inc.
Your Trusted Partner in Chemical Regulatory Compliance
Established in 2005, DORUKSISTEM has carved a niche for itself as a preeminent consultancy firm, specializing in guiding chemical manufacturers, exporters, and importers through the labyrinthine complexities of Turkish, European Union, and global chemical regulations.
Our Vision
To be the most preferred solution center of our customers in terms of compliance with chemical regulations and sustainability services.
Our Mission
OTo provide our customers with the highest level of access to chemical regulations compliance and sustainability services.
Comprehensive Suite of Services
Regulatory Compliance
We offer an exhaustive range of services aimed at ensuring your business is in full compliance with intricate Turkish and EU chemical regulations, such as KKDIK, REACH, and SEVESO II & III. Our team of experts conducts thorough audits, provides actionable insights, and assists in the implementation of compliance measures.
Quality Systems Installation
Our consultancy extends beyond mere compliance. We design and implement state-of-the-art quality management systems that are customized to meet the unique operational needs of each client in the chemical industry.
Research & Development Support
In a rapidly evolving industry landscape, staying ahead of the curve is essential. We offer robust R&D support services, including product development and innovation strategies, to ensure your business remains at the forefront of industry advancements.
Chemical Safety Management
Safety is not just a regulatory requirement but a moral obligation. We assist in establishing comprehensive chemical safety management systems that prioritize the well-being of your workforce and the environment.
Safety Data Sheet Authoring & Label Validation
Our team of experts meticulously authors Safety Data Sheets and validates product labels to ensure full compliance with regulatory standards, thereby mitigating any legal risks.
Technical System Design for Safety and Health Applications
We specialize in the design of technical systems that prioritize safety and health within chemical plants. Our bespoke solutions are engineered to meet the highest standards of operational safety.
Licensing & Certification
Navigating local legislation can be a daunting task. We simplify this process by facilitating the licensing of chemical manufacturing premises and offering a range of industry-specific certifications.
Global Reach, Local Expertise
With an established presence in Turkey and the European Union, DORUKSISTEM has successfully provided cost-effective, high-quality regulatory compliance support and testing services to a diverse portfolio of companies. Our global reach is complemented by our deep local expertise, making us the consultancy of choice for businesses operating in Turkey and the EU.
DORUKSISTEM has been established in 2005 to guide and lead to the chemical manufacturers, exporters and importers for the compliance of Turkish, Europian Union and Global chemical regulations.
DORUKSISTEM is a leading service provider of regulatory compliance management, consulting and testing services with a strong focus on chemical and related industries in Türkiye.
With a strong presence in TURKIYE, Doruksistem has provided cost-effective regulatory compliance support and testing services to lots of companies while doing businesses in TURKIYE and EU.
As Doruksistem Consulting, we serve our customers in the following areas:
Turkish Chemicals Regulations
Important Regulatory Update: Introduction of New Chemical Regulations in the Republic of Turkey
In a significant legislative development, the Republic of Turkey has recently enacted a comprehensive set of regulations like KKDIK that mandate the formal registration of chemical substances for all importers and manufacturers operating within its jurisdiction. If your enterprise is involved in the placement of chemical substances, mixtures, preparations, formulations or articles on the Turkish market, it is crucial to be fully apprised of these new regulatory requirements, as non-compliance could result in severe legal repercussions.
Key Compliance Requirements
To adhere to these newly promulgated regulations like KKDIK and SEA it is incumbent upon your organization to:
Thoroughly Understand Regulatory Specifications: Familiarize yourself with the intricate details of the new legislative framework to ascertain the specific obligations that apply to your business operations.
Complete Mandatory Registration: If your business activities fall within the scope of these regulations, you are required to submit a formal registration. This process must be conducted in the Turkish language.
Utilize Designated IT Tools: The Turkish authorities have made available specialized Information Technology tools—namely, ECBS & KKS—for the purpose of facilitating the registration process. It is imperative to use these platforms for submission of all required documentation.
By diligently adhering to these stipulations, you not only ensure your organization’s compliance with Turkish law but also mitigate the risk of incurring legal penalties or market access restrictions.
Our services include:
- KKDIK Regulatory Compliance Consulting and Training;
- KKDIK Only Representative (OR) Service;
- KKDIK Compliance Audits
- Defining KKDIK strategy for compliance
- KKDIK Pre-registrations (Pre-SIEF Registration and C&L Notification)
- KKDIK Registrations (as Lead Registrant and Co-Registrant)
- KKDIK MBDF/SIEF pre- and post- communication and management
- KKDIK CAS/KDU Trainings according to Annex XVIII
- Turkiye SEA/CLP Regulation Regulatory Compliance Consulting and Training;
- C&L Notification under Turkiye CLP Regulation;
- Turkiye CLP Regulation OR Service;
- Turkish SDS and Labeling Preparation according to KKDIK Annex II by certified KDU experts
- Exposure Scenarios with handled methodologies in house
- Training TURKREACH/KKDIK, TR-SDS, TR-CLP, TR-BPR
- TR Representative Biocides
- CLP/GHS classification and labelling in Turkish
Global Chemical Compliance Services
- REACH (1907/2006) Compliance Services
- REACH (1907/2006) Legislation Practices and “Only Representative ” Services
- REACH Registration Dossier preparing
- Technical files and Chemical Safety Report preperation,
- Exposure scenerio preparing
- REACH Compliance testings and analyzing
- Only Representative services
- Risk Engineering and Proses Safety
- SEVESO Regulation Compliance Management
- Global Chemical Regulations Compliance Services
System Certification and Assessment Services
- ISO 9001 Quality Management System Certification and Consulting
- ISO 14001 Environmental Management System Certification and Consulting
- OHSAS 18001 Occupational Health and Safety Certification and Consulting
- ISO 22000 Food Safety (HACCP) Certification and Consulting
- TSE Certificate of Location Services
- TSE Certificate of Conformity
- TSE Product Quality Certificate
- The Ministry of Health Product Licensing
- Kimyasal Güvenlik Değerlendirme
- Chemical Safety Assessment
- CMR and Nanometaryal Assessment
- GMP Documentation
- Detergent Regulation Assessment
- Biocidal Products Regulations Assessment
Doruksistem is an authorized training company for CAS/KDU trainings by Turkish Ministry of Environment, Urbanisation and Climate Change (MoEUCC)
- Ministry of Environment, Urbanisation, and Climate Change, Türkiye
- Ministry of Health, Türkiye
- Ministry of Trade, Türkiye
- National Poison Center, Türkiye
- ECHA - Europian Chemical Agency
- The REACH CENTER , Lancaster University, UK
DORUKSISTEM Service Philosophy
Creativity
At Doruksistem, we pride ourselves on our ability to harness scientific acumen and collaborative synergy to deliver bespoke, cutting-edge solutions. Our consultants are adept at rapidly addressing multifaceted challenges, thereby optimizing cost-efficiency. We proactively anticipate the needs of our clients, ensuring that their interests are at the forefront of our strategic planning.
Integrity
We hold each client in high esteem, recognizing the intrinsic value they bring to our professional relationship. Our unwavering commitment to ethical conduct and transparency distinguishes us as a consultancy firm of repute. We endeavor to provide unparalleled services, aspiring to reciprocate the respect accorded to us by our esteemed clientele.
Responsibility
Comprehending the imperative nature of regulatory compliance and safeguarding business interests, we exercise rigorous responsibility in our consultancy practice. Our advisory services are meticulously designed to mitigate business risks and confer competitive advantages, all within the purview of pertinent chemical regulations such as KKDIK, SEA, GBF, Biocidal, and Cosmetic directives.
Sustainability
To us, sustainability is not merely a term but a guiding principle. We are unequivocally committed to the notion that sustainable development is the panacea for contemporary environmental and health-related challenges. Our objective transcends ephemeral gains; we are resolute in our ambition to cultivate enduring partnerships with our clients, facilitating mutual growth and prosperity.
